Parkinson's disease
Conditions
Interventions
The volunteer will be given the CLE-600 oral system which contains 50 mg
carbidopa and 500 mg levodopa twice (one administration per evening on 2
consecutive evenings) as an oral capsule with 240 mi
Sponsors
Clexio Biosciences Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Sex : male or female; females must be of nonchildbearing potential or postmenopausal. 2. Age : 40 to 80 years, inclusive, at screening. 3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening. 4. Weight : >=50 kg, at screening. 5. Status : PD patients (diagnosed according to UK PD Society Brain Bank Criteria). Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of ICON or the Sponsor. 3. History of alcohol abuse or drug addiction within the last year (including soft drugs like cannabis products), except for tobacco use disorder. 4. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, and alcohol) at screening or admission (Day 1 for Part A and Day -1 for Part B) to the clinical research center. For cannabinoids, in case of a positive screen the Investigator should decide whether this is related to medical or recreational use (then subject may be included) or to drug addiction (then subject should be excluded). 5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - CD and LD PK parameters: Cmax, Tc above 450ng/ml, Tmax, AUC0-t, AUC0-inf, t1/2, Tlag as applicable - Safety and tolerability: Incidence of adverse events, vital signs, clinical laboratory tests and ECG | — |
Countries
Netherlands
Outcome results
None listed